Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1; Implantable Cardioverter Defibrillators

Hazard

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

Details from the source

Reason for recall: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds. Distribution: US Nationwide - Worldwide Distribution Quantity: 2173 units Lot/code info: GTIN 00643169837683, Lot Serial Numbers: RPU202561H, RPU202848H, RPU202573H, RPU203658H, RPU203285H, RPU203317H, RPU203431H, RPU203502H, RPU203716H, RPU203301H, RPU203534H, RPU203203H, RPU203261H, RPU203298H, RPU203066H, RPU203286H, RPU202440H, RPU202452H, RPU202505H, RPU202580H, RPU202588H, RPU202610H, RPU202614H, RPU202616H, RPU202617H, RPU202619H, RPU202624H, RPU202690H, RPU202707H, RPU202829H, RPU202831H, RPU202834H, RPU202914H, RPU203010H, RPU203011H, RPU203012H, RPU203013H, RPU203017H, RPU203018H, RPU203019H, RPU203021H, RPU203159H, RPU203161H, RPU203205H, RPU203486H, RPU203494H, RPU203242H, RPU203690H, RPU203709H, RPU203138H, RPU202362H, RPU202206H, RPU202274H, RPU202493H, RPU202529H, RPU202874H, RPU203234H, RPU203405H, RPU202258H, RPU202269H, RPU202642H, RPU202948H, RPU203105H, RPU203278H, RPU203104H, RPU202960H, RPU202775H, RPU203122H, RPU203648H, RPU202139H, RPU202324H, RPU202745H, RPU202577H, RPU203031H, RPU203300H, RPU202814H, RPU202388H, RPU202818H, RPU203357H, RPU203517H, RPU203676H, RPU203480H, RPU203639H, RPU202382H, RPU203320H, RPU203581H, RPU202260H, RPU202534H, RPU203529H, RPU203733H, RPU202478H, RPU203413H, RPU202601H, RPU202861H, RPU203150H, RPU202884H, RPU202433H, RPU202448H, RPU203699H, RPU202662H, RPU202767H, RPU203734H, RPU203007H, RPU203142H, RPU203145H, RPU203257H, RPU203280H, RPU203492H, RPU203677H, RPU203687H, RPU203688H, RPU202248H, RPU203265H, RPU202194H, RPU202195H, RPU202196H, RPU202197H, RPU202200H, RPU202202H, RPU202396H, RPU202628H, RPU2026

UPC codes

00643169837683, 00763000059682

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.